For more than two decades, American women have been prescribed Zofran, a powerful antiemetic medication, to help overcome the common nausea and vomiting that accompanies early pregnancy. But neither Zofran, nor its active ingredient ondansetron, were ever approved for this use.
Zofran is intended for patients suffering severe nausea after cancer therapy and surgical procedures. And even though it is illegal to promote a drug “off-label,” Zofran’s manufacturer, pharmaceutical giant GlaxoSmithKline was accused of explicitly marketing the drug to physicians for the treatment of morning sickness. That is just part of what the US Department of Justice claimed in a record-breaking lawsuit that GSK ultimately settled for $3 billion.
But at the time, the full consequences of GlaxoSmithKline’s allegedly illegal marketing weren’t clear. Hundreds of thousands of pregnant women were prescribed ondansetron, by physicians who had no evidence that the drug would harm unborn babies. Now, large-scale medical studies have found a link between ondansetron and severe birth defects.
Can I File A Zofran Birth Defect Lawsuit?
Recent studies have uncovered the troubling association between ondansetron and birth defects. At the same time, it’s quite possible that GlaxoSmithKline may not have fully disclosed similar results to federal regulators and the public. If you took Zofran and delivered a baby with birth defects, it would be natural to ask whether or not GlaxoSmithKline is liable for the harm done to your child.
Hundreds of families have already filed lawsuits, claiming that GlaxoSmithKline knew of Zofran’s devastating effects on fetal development, but did nothing to warn the public or medical professionals.
Because every situation is different, we cannot tell you whether or not you have a case right now. But it’s possible that you may be entitled to significant compensation and we will conduct an evaluation of your claim for free.
The experienced firm of Monheit Law is here to answer any questions you have. Just call 877-620-8411 to learn more about your legal options. Your consultation is free, and you have no obligations afterward. Just call to get the legal answers your family deserves.
Below, you’ll find answers to our most frequently asked questions, as well as a discussion of the allegations from the complaint filed against GlaxoSmithKline for potential liability for birth defects that may have been caused by ondansetron.
Is The $3 Billion Settlement Intended To Compensate Families?
No. GlaxoSmithKline’s settlement was meant to “resolve” the Department of Justice’s allegations, which only included marketing Zofran to physicians and patients for unapproved “off-label” purposes.
The DOJ’s case had nothing to do with whether or not Zofran could cause birth defects, or whether or not GlaxoSmithKline was aware of ondansetron’s dangers. It is only now, after potentially damning allegations have come to light, that families who believe that they have been harmed by GlaxoSmithKline are filing lawsuits to pursue justice.
Did GlaxoSmithKline Know That Zofran Was Dangerous?
This is the distressing allegation that recent lawsuits have made, and the question upon which the litigation will hinge.
The complaints allege that, at the least, GlaxoSmithKline should have known of possible dangers and should have conducted further studies to determine the truth.
In the 1980s, GSK performed a series of tests on pregnant rats and rabbits. While the animals experienced an abnormally high incidence of fetal anomalies, and multiple stillbirths, GlaxoSmithKline seems to have “failed” to report these results to the FDA.
By 1991, Zofran was approved for use in cancer patients.
In their case, the DOJ alleged that GlaxoSmithKline began marketing the drug for morning sickness soon after, without performing any of the necessary safety trials. That same year, GSK received its first two reports of birth defects, which involved pregnant women who had taken Zofran during their first trimester.
32 separate reports of Zofran-related birth defects were submitted to GSK by 2000. As of 2015, GlaxoSmithKline has received over 200 birth defect reports. But the company has done nothing to Zofran’s labeling that would notify physicians or the public of these dangers. Nor has GSK initiated its own clinical trials to investigate Zofran’s potential for fetal harm.
To date, GlaxoSmithKline has received the results of at least three epidemiological studies that may indicate an increased risk of birth defects in children born to women who took Zofran.
The complaints allege that GSK was aware of these studies indicating the potential of ondansetron’s possibly harmful effects on unborn children, but marketed Zofran to the OB/GYN’s of pregnant women anyway. If this is true, any woman who took Zofran and then delivered a baby with birth defects, could bring a claim for substantial compensation for her child.
How Much Is My Zofran Lawsuit Worth?
With numerous cases filed, but no verdicts or settlements made public, it’s impossible for us to value a Zofran birth defect case at this time. The amount to which your family is entitled will depend on a wide range of factors, including the severity of your child’s defects.
With that being said, a personal injury lawsuit will allow you to pursue claims for:
- Medical expenses, past and future
- Pain and suffering
- Emotional distress
- Loss in quality of life
- Loss of consortium
For more information on the damages available in a civil lawsuit, click here.
Is There A Statute Of Limitations?
A “statute of limitations” is like a legal time limit: after the statute of limitations is up, you will no longer be able to file a lawsuit. But since each state determines its own limitations, there’s no one answer to this question.
Many states extend families longer statutes of limitation for cases that involve children. Some states will begin the time period in which you can file a lawsuit on the date that your child turns a certain age, for example 18. Other states have much shorter time limits, so do not delay!
Lawsuits have alleged that GlaxoSmithKline’s possible concealment of vital information adds its own wrinkle to this question. Because if patients were never given the opportunity to know of the potential dangers linked to Zofran until now, then how can the law expect them to have filed suit before that? If true, in some states this may be able to “toll,” extend or suspend the statute of limitations in your case.
In other words, a lawsuit against GlaxoSmithKline may be possible even for children born years ago. In fact, some Zofran lawsuits even involve children born a decade ago.
Is This A Class Action?
No. Many cases against large companies become “class actions”; individual complaints are bundled together and litigated in a single lawsuit. Zofran birth defect lawsuits will be different, because each family’s situation itself is different.
What If I Took Generic Ondansetron?
We are currently investigating cases involving generic forms of ondansetron, as well as claims involving GlaxoSmithKline’s branded product Zofran. If you took any form of ondansetron, including:
- Ondansetron hydrochloride,
- Ondansetron hydrochloride & dextrose or
- Ondansetron hydrochloride & sodium chloride
and delivered a child with birth defects, you may be eligible to pursue compensation.
If you have any concerns regarding the eligibility of your case, or simply want to learn more, contact the experienced attorneys at Monheit Law to speak with someone who can help.
Call us toll-free at 877-620-8411 or complete our contact form to get started.